SUMMARY:

The Investigator is responsible to lead, conduct and document investigations relating to non-conformances and/or complaints within a GMP Pharmaceutical packaging organization. The Investigator will utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of non-conformances/complaints. The Investigator will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation. The Investigator will lead, as necessary, the implementation of associated corrective and preventative actions through collaboration, teamwork, and influence. The position will work closely and in collaboration with internal and occasionally external stakeholders. The Investigator also has responsibilities for data generation, process evaluation and performance metrics for the purposes of customer communication and driving continuous improvement.
Must possess a working knowledge of FDA regulations pertaining to Pharmaceutical /Pharmaceutical Packaging Operations and a high level for detail and accuracy.
Scope of the position includes Allentown, Macungie and/or Conshohocken. The impact of decisions relating to customer interface, investigation conclusions, and documentation supporting recommendations for product impact assessments could expose the company to significant risk or economic loss.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities for the Investigator. Other duties may also be assigned.

• Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.
• Conduct investigations that identify robust root cause by effectively applying root cause analysis tools across a variety of non-conformance and/or complaint types.
• Independently lead and/or facilitate floor gembas, cross functional meetings, and operator interviews related to investigations.
• Observe processes on shop floor, warehouse, and central support functions (incoming inspection, sales, customer service, project management, validation, and engineering) to ensure investigation is factual and detailed.
• Author investigation reports in designated QMS utilizing strong organizational and technical writing skills with demonstrated attention to detail.
• Drives collaboration utilizing strong interpersonal communication skills.
• Lead effective cross-functional root cause analysis and CAPA and Continuous Improvement planning and execution with minimal supervision.
• Owns data collection and performance metrics relative to the investigation process and CAPA effectiveness and facilitates sharing of investigational findings and risk knowledge through the organization.
• Initiates, writes, reviews, and assesses change controls and revises SOPs and Work Instructions as needed for action implementation.
• Utilizes knowledge, experience, and critical thinking skills to recommend potential product impact outcomes and provides thorough supporting documentation and justification for those outcomes.
• Ability to thrive in a dynamic environment, multi-task, and independently prioritize and manage timelines to support packaging schedule, product disposition and release in alignment with organizational and customer goals.
• Supports customer relationships related to investigation findings, CAPA implementation and performance metrics and process improvements.
• Supports customer and regulatory audits as needed by presenting investigation summary and conclusions in a thoughtful, clear, and concise manner.
• Lead continuous improvement efforts focused on investigation related processes or the reduction and/or elimination of organizational risk by closing GMP gaps.
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs.
• Proactively identify and facilitate resolution of potential risks.
• Must be flexible to meet the needs to the organization when required.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIREMENTS:

Due to the nature of our work, all employees must be over the age of 18 and will be required to undergo a pre-employment drug test and background check.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree is preferred with one to three years related experience or Associate’s Degree with three to five years of related experience. Experience in the packaging or inspection of pharmaceutical products or related industry is required. Experience in the design, documentation, operation, maintenance, and/or improvement of biopharma facilities is preferred. Outside certification of quality skills and practices (i.e., ASQ, CQIA, CQI, CQT, Lean Six Sigma etc.) is highly desired.

MATHEMATICAL SKILLS:

Ability to apply moderately complex mathematical operations including an understanding of statistical skills.

LANGUAGE SKILLS:

Ability to effectively communicate (written and verbally) with the following groups:
Internal Communication: Quality, Operations, Sales, Customer Service, Project Management, Validation, and Engineering teams.
External Communication: Represents Quality as the subject matter expert (SME) for customers and regulatory agencies on Investigations related non-conforming events.

WRITTEN SKILLS:

High level of writing and verbal skills, ability to provide clear, concise, and legible communication within investigation reports, internal and external correspondence, such as memos to file, electronic mail and investigation reports and procedure writing.

COMPUTER SKILLS:

Intermediate Windows applications including the Microsoft Office Suite and electronic QMS.

ESSENTIAL DUTIES AND RESPONSIBILITIES: The following is a list of minimum responsibilities for the Investigator. Other duties may also be assigned.

• Identifies issues and can independently assess the need for non-conformance and formulate recommended containment actions in conjunction with operational leadership.
• Conduct investigations that identify robust root cause by effectively applying root cause analysis tools across a variety of non-conformance and/or complaint types.
• Independently lead and/or facilitate floor gembas, cross functional meetings, and operator interviews related to investigations.
• Observe processes on shop floor, warehouse, and central support functions (incoming inspection, sales, customer service, project management, validation, and engineering) to ensure investigation is factual and detailed.
• Author investigation reports in designated QMS utilizing strong organizational and technical writing skills with demonstrated attention to detail.
• Drives collaboration utilizing strong interpersonal communication skills.
• Lead effective cross-functional root cause analysis and CAPA and Continuous Improvement planning and execution with minimal supervision.
• Owns data collection and performance metrics relative to the investigation process and CAPA effectiveness and facilitates sharing of investigational findings and risk knowledge through the organization.
• Initiates, writes, reviews, and assesses change controls and revises SOPs and Work Instructions as needed for action implementation.
• Utilizes knowledge, experience, and critical thinking skills to recommend potential product impact outcomes and provides thorough supporting documentation and justification for those outcomes.
• Ability to thrive in a dynamic environment, multi-task, and independently prioritize and manage timelines to support packaging schedule, product disposition and release in alignment with organizational and customer goals.
• Supports customer relationships related to investigation findings, CAPA implementation and performance metrics and process improvements.
• Supports customer and regulatory audits as needed by presenting investigation summary and conclusions in a thoughtful, clear, and concise manner.
• Lead continuous improvement efforts focused on investigation related processes or the reduction and/or elimination of organizational risk by closing GMP gaps.
• Complete QMS actions related to change controls, non-conformance, complaints and CAPAs.
• Proactively identify and facilitate resolution of potential risks.
• Must be flexible to meet the needs to the organization when required